MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	54850017545
Medical Device Problem Code	Metal Shedding Debris (1804)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on an unknown date, post-op, patient presented to surgeon with pain.Bone scan completed and showed hot spots at l3 and s1.Surgeon decided to reoperate and replace the screw in revision surgery.During removal, surgeon noticed a large amount of metallosis on the left l3 level.
Additional Manufacturer Narrative
Product analysis: the bone screw saddle has witness marks across the face.There are also witness marks on the side of the screw head from off axis pressure.The witness marks align with the witness marks on the rod.Conclusion:the root cause of the one set screw backing out is consistent with angle of the rod in respect to the saddle of the bone screw.This allowed the rod to move inside the bone screw head, removing material from the set screw.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SOLERA SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 7618083
• Report Number: 1030489-2018-00866
• Device Sequence Number: 1694567
• Product Code: NKB
• UDI-Device Identifier: 00643169491649
• UDI-Public: 00643169491649
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 54850017545
• Device Lot Number: H5288417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 83